Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿; PISTON SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿; PISTON SYRINGE Back to Search Results
Catalog Number 309644
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2022
Event Type  malfunction  
Event Description
It was reported while using bd syringe with hypodermic needle precisionglide¿ a crack in the syringe caused blood leakage.There was no report of patient impact.The following information was provided by the initial reporter: a user facility clinic manager reported to customer service that there were cracks in the barrel of the syringe due to a potential loose seal and causing contents/blood to squirt out when pushing contents in.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Event Description
It was reported while using bd syringe with hypodermic needle precisionglide¿ a crack in the syringe caused blood leakage.There was no report of patient impact.The following information was provided by the initial reporter: a user facility clinic manager reported to customer service that there were cracks in the barrel of the syringe due to a potential loose seal and causing contents/blood to squirt out when pushing contents in.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15524638
MDR Text Key306330282
Report Number1213809-2022-00665
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903096442
UDI-Public00382903096442
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number309644
Device Lot Number1341605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-